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Last Updated: January 30, 2026

Details for New Drug Application (NDA): 206053


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NDA 206053 describes LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, which is a drug marketed by Dr Reddys Labs Sa, Lupin Ltd, and Xiromed, and is included in seven NDAs. It is available from five suppliers. Additional details are available on the LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL profile page.

The generic ingredient in LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 206053
Tradename:LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
Applicant:Xiromed
Ingredient:ethinyl estradiol; levonorgestrel
Patents:0
Suppliers and Packaging for NDA: 206053
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 206053 ANDA Mylan Pharmaceuticals Inc. 0378-7316 0378-7316-85 1 POUCH in 1 CARTON (0378-7316-85) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 206053 ANDA Xiromed, LLC 70700-312 70700-312-87 1 POUCH in 1 CARTON (70700-312-87) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A
Approval Date:Oct 2, 2017TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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